ChiCTR2300071235 版本V1.0 版本创建时间2023/05/09 09:11:47 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2300071235 

最近更新日期：

Date of Last Refreshed on：

 2023-05-09 09:11:39 

注册时间：

Date of Registration：

 2023-05-09 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

Please fill in the link to the data management platform. Opening the black box of a multicomponent intervention for informal dementia caregivers: A randomized controlled trial using the Multiphase Optimization Strategy (MOST)

Public title：

Opening the black box of a multicomponent intervention for informal dementia caregivers: A randomized controlled trial using the Multiphase Optimization Strategy (MOST)

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Opening the black box of a multicomponent intervention for informal dementia caregivers: A randomized controlled trial using the Multiphase Optimization Strategy (MOST)

Scientific title：

Opening the black box of a multicomponent intervention for informal dementia caregivers: A randomized controlled trial using the Multiphase Optimization Strategy (MOST)

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

Dr CHOU Kee Lee 

研究负责人：

Dr CHOU Kee Lee 

Applicant：

Dr CHOU Kee Lee 

Study leader：

Dr CHOU Kee Lee 

申请注册联系人电话：

Applicant telephone：

 +852 18 29487473

研究负责人电话：

Study leader's
telephone：

+852 18 29487473

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 klchou@eduhk.hk

研究负责人电子邮件：

Study leader's E-mail：

 klchou@eduhk.hk

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

10 Lo Ping Road, B2-1/F-04 DID: +852 29487473

研究负责人通讯地址：

10 Lo Ping Road, B2-1/F-04 DID: +852 29487473

Applicant address：

10 Lo Ping Road, B2-1/F-04 DID: +852 29487473

Study leader's address：

10 Lo Ping Road, B2-1/F-04 DID: +852 29487473

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

The Education University of Hong Kong

Applicant's institution：

The Education University of Hong Kong

研究负责人所在单位：

The Education University of Hong Kong

Affiliation of the Leader：

The Education University of Hong Kong

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 A2020-2021-0045

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

The Education University of Hong Kong, Human Research Ethics Committee

Name of the ethic committee：

The Education University of Hong Kong, Human Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2021-08-18 00:00:00

伦理委员会联系人：

Patsy Chung

Contact Name of the ethic committee：

Patsy Chung

伦理委员会联系地址：

Human Research Ethics Committee (HREC) Secretariat c/o Research and Development Office D4-1/F-21, The Education University of Hong Kong

Contact Address of the ethic committee：

Human Research Ethics Committee (HREC) Secretariat c/o Research and Development Office D4-1/F-21, The Education University of Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 18 29488120

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 +852 29488120

研究实施负责（组长）单位：

The Education University of Hong Kong

Primary sponsor：

The Education University of Hong Kong

研究实施负责（组长）单位地址：

10 Lo Ping Road, Tai Po, New Territories, Hong Kong

Primary sponsor's address：

10 Lo Ping Road, Tai Po, New Territories, Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

China

省(直辖市)：

Hong Kong

市(区县)：

Country：

China

Province：

Hong Kong

City：

单位(医院)：

Research Office (Research Fund Secretariat), Health Bureau

具体地址：

9/F, Rumsey Street Multi-storey Carpark Building 2 Rumsey Street, Sheung Wan

Institution
hospital：

Research Office (Research Fund Secretariat), Health Bureau

Address：

9/F, Rumsey Street Multi-storey Carpark Building 2 Rumsey Street, Sheung Wan

经费或物资来源：

HMRF - Health and Health Services (former HHSRF), Research Fund Secretariat, Health Bureau

Source(s) of funding：

HMRF - Health and Health Services (former HHSRF), Research Fund Secretariat, Health Bureau

研究疾病：

Dementia  

Target disease：

Dementia

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

The purpose of this proposed study is to determine the implementation fidelity of each 6 components and to examine which components are most strongly associated with primary outcomes and which led to improvements in corresponding proximal outcomes. Also, we want to determine the interaction effect between components on their proximal outcomes and primary outcomes and the moderating effect of baseline scores of primary outcomes in the link.  

Objectives of Study：

The purpose of this proposed study is to determine the implementation fidelity of each 6 components and to examine which components are most strongly associated with primary outcomes and which led to improvements in corresponding proximal outcomes. Also, we want to determine the interaction effect between components on their proximal outcomes and primary outcomes and the moderating effect of baseline scores of primary outcomes in the link.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

The inclusion criteria for family caregivers requires that they be: 1) Chinese citizens who are at least 18 years old; 2) the spouse, adult child, or child-in-law of a care recipient; 3) without cognitive impairment (i.e., MMSE scores ≥23); 4) the primary family caregiver (at least 20 hours per week) for an individual with dementia and that they have filled this role for at least one year. People are considered as care providers if they help an individual with dementia in carrying out their ADLs and IADLs. To avoid the problem of the heterogeneity, we one inclusion criterion requiring caregivers to have experienced at least some symptoms of depression or feelings of burden (CES-D > 12 or Zarit Burden Scale > 18).

Inclusion criteria

The inclusion criteria for family caregivers requires that they be: 1) Chinese citizens who are at least 18 years old; 2) the spouse, adult child, or child-in-law of a care recipient; 3) without cognitive impairment (i.e., MMSE scores ≥23); 4) the primary family caregiver (at least 20 hours per week) for an individual with dementia and that they have filled this role for at least one year. People are considered as care providers if they help an individual with dementia in carrying out their ADLs and IADLs. To avoid the problem of the heterogeneity, we one inclusion criterion requiring caregivers to have experienced at least some symptoms of depression or feelings of burden (CES-D > 12 or Zarit Burden Scale > 18).

排除标准：

Participants who do not meet the inclusion criteria

Exclusion criteria：

Participants who do not meet the inclusion criteria

研究实施时间：

Study execute time：

从 From 2021-04-01 00:00:00至 To 2023-11-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2021-06-01 00:00:00 至 To 2022-12-31 00:00:00

干预措施：

Interventions：

组别：

1

样本量：

 16

Group：

1

Sample size：

干预措施：

All Components (1-6) 1: Dementia & caregiver education 2. Self-care skills 3. Behavioral problems management 4. Behavioral activation 5. Mindfulness yoga 6. Social Support

干预措施代码：

Intervention：

All Components (1-6) 1: Dementia & caregiver education 2. Self-care skills 3. Behavioral problems management 4. Behavioral activation 5. Mindfulness yoga 6. Social Support

Intervention code：

组别：

2

样本量：

 16

Group：

2

Sample size：

干预措施：

Components 1-4 1: Dementia & caregiver education 2. Self-care skills 3. Behavioral problems management 4. Behavioral activation

干预措施代码：

Intervention：

Components 1-4 1: Dementia & caregiver education 2. Self-care skills 3. Behavioral problems management 4. Behavioral activation

Intervention code：

组别：

3

样本量：

 16

Group：

3

Sample size：

干预措施：

Components 1-3 & 5 1: Dementia & caregiver education 2. Self-care skills 3. Behavioral problems management 5. Mindfulness yoga

干预措施代码：

Intervention：

Components 1-3 & 5 1: Dementia & caregiver education 2. Self-care skills 3. Behavioral problems management 5. Mindfulness yoga

Intervention code：

组别：

4

样本量：

 16

Group：

4

Sample size：

干预措施：

Components 1-3 & 6 1: Dementia & caregiver education 2. Self-care skills 3. Behavioral problems management 6. Social Support

干预措施代码：

Intervention：

Components 1-3 & 6 1: Dementia & caregiver education 2. Self-care skills 3. Behavioral problems management 6. Social Support

Intervention code：

组别：

5

样本量：

 16

Group：

5

Sample size：

干预措施：

Components 1-2 & 4-5 1: Dementia & caregiver education 2. Self-care skills 4. Behavioral activation 5. Mindfulness yoga

干预措施代码：

Intervention：

Components 1-2 & 4-5 1: Dementia & caregiver education 2. Self-care skills 4. Behavioral activation 5. Mindfulness yoga

Intervention code：

组别：

6

样本量：

 16

Group：

6

Sample size：

干预措施：

Components 1-2, 4 & 6 1: Dementia & caregiver education 2. Self-care skills 4. Behavioral activation 6. Social Support

干预措施代码：

Intervention：

Components 1-2, 4 & 6 1: Dementia & caregiver education 2. Self-care skills 4. Behavioral activation 6. Social Support

Intervention code：

组别：

7

样本量：

 16

Group：

7

Sample size：

干预措施：

Components 1-2 & 5-6 1: Dementia & caregiver education 2. Self-care skills 5. Mindfulness yoga 6. Social Support

干预措施代码：

Intervention：

Components 1-2 & 5-6 1: Dementia & caregiver education 2. Self-care skills 5. Mindfulness yoga 6. Social Support

Intervention code：

组别：

8

样本量：

 16

Group：

8

Sample size：

干预措施：

Components 1 & 2 1: Dementia & caregiver education 2. Self-care skills

干预措施代码：

Intervention：

Components 1 & 2 1: Dementia & caregiver education 2. Self-care skills

Intervention code：

组别：

9

样本量：

 16

Group：

9

Sample size：

干预措施：

Components 1 & 3-5 1: Dementia & caregiver education 3. Behavioral problems management 4. Behavioral activation 5. Mindfulness yoga

干预措施代码：

Intervention：

Components 1 & 3-5 1: Dementia & caregiver education 3. Behavioral problems management 4. Behavioral activation 5. Mindfulness yoga

Intervention code：

组别：

10

样本量：

 16

Group：

10

Sample size：

干预措施：

Components 1, 3-4 & 6 1: Dementia & caregiver education 3. Behavioral problems management 4. Behavioral activation 6. Social Support

干预措施代码：

Intervention：

Components 1, 3-4 & 6 1: Dementia & caregiver education 3. Behavioral problems management 4. Behavioral activation 6. Social Support

Intervention code：

组别：

11

样本量：

 15

Group：

11

Sample size：

干预措施：

Components 1, 3 & 5-6 1: Dementia & caregiver education 3. Behavioral problems management 5. Mindfulness yoga 6. Social Support

干预措施代码：

Intervention：

Components 1, 3 & 5-6 1: Dementia & caregiver education 3. Behavioral problems management 5. Mindfulness yoga 6. Social Support

Intervention code：

组别：

12

样本量：

 15

Group：

12

Sample size：

干预措施：

Components 1 & 3 1: Dementia & caregiver education 3. Behavioral problems management

干预措施代码：

Intervention：

Components 1 & 3 1: Dementia & caregiver education 3. Behavioral problems management

Intervention code：

组别：

13

样本量：

 15

Group：

13

Sample size：

干预措施：

Components 1 & 4-6 1: Dementia & caregiver education 4. Behavioral activation 5. Mindfulness yoga 6. Social Support

干预措施代码：

Intervention：

Components 1 & 4-6 1: Dementia & caregiver education 4. Behavioral activation 5. Mindfulness yoga 6. Social Support

Intervention code：

组别：

14

样本量：

 15

Group：

14

Sample size：

干预措施：

Components 1 & 4 1: Dementia & caregiver education 4. Behavioral activation

干预措施代码：

Intervention：

Components 1 & 4 1: Dementia & caregiver education 4. Behavioral activation

Intervention code：

组别：

15

样本量：

 15

Group：

15

Sample size：

干预措施：

Components 1 & 5 1: Dementia & caregiver education 5. Mindfulness yoga

干预措施代码：

Intervention：

Components 1 & 5 1: Dementia & caregiver education 5. Mindfulness yoga

Intervention code：

组别：

16

样本量：

 15

Group：

16

Sample size：

干预措施：

Components 1 & 6 1: Dementia & caregiver education 6. Social Support

干预措施代码：

Intervention：

Components 1 & 6 1: Dementia & caregiver education 6. Social Support

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 Hong Kong 

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

 Non-governmental Organization 

单位级别：

 Community 

Institution
hospital：

Non-governmental Organization

Level of the institution：

Community

测量指标：

Outcomes：

指标中文名：

physical health status

指标类型：

主要指标

Outcome：

physical health status

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

stress/caregiving burden

指标类型：

主要指标

Outcome：

stress/caregiving burden

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

psychological well-being

指标类型：

主要指标

Outcome：

psychological well-being

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

anxiety/depressive symptoms

指标类型：

主要指标

Outcome：

anxiety/depressive symptoms

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

social support

指标类型：

主要指标

Outcome：

social support

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

self care

指标类型：

次要指标

Outcome：

self care

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

dementia care strategies

指标类型：

次要指标

Outcome：

dementia care strategies

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

engagement in pleasurable activities

指标类型：

次要指标

Outcome：

engagement in pleasurable activities

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

mindfulness attention awareness

指标类型：

次要指标

Outcome：

mindfulness attention awareness

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

satisfaction with support group

指标类型：

次要指标

Outcome：

satisfaction with support group

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

NA

组织：

NA

Sample Name：

NA

Tissue：

NA

人体标本去向

 其它  

说明

NA

Fate of sample：

0thers  

Note：

NA

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 80 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

Participants will be randomly assigned to one of the 16 experimental conditions (ECs) using computer generated random numbers. All participants will receive Component 1 (Dementia and Caregiver Education) as the core intervention. Using a fractional factorial MOST design, participants will be randomly assigned to one of 16 experimental conditions that vary the delivery of treatment components. Thus, for each component, some participants will serve as the experimental (treatment) group and some will be controls. This will allow for testing the effects of each component.

Randomization Procedure (please state who generates the random number sequence and by what method)：

Participants will be randomly assigned to one of the 16 experimental conditions (ECs) using computer generated random numbers. All participants will receive Component 1 (Dementia and Caregiver Education) as the core intervention. Using a fractional factorial MOST design, participants will be randomly assigned to one of 16 experimental conditions that vary the delivery of treatment components. Thus, for each component, some participants will serve as the experimental (treatment) group and some will be controls. This will allow for testing the effects of each component.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

Participants will be randomly assigned to one of the 16 experimental conditions using computer generated random numbers. No interaction between participants will occur, thus the experimental conditions will be blinded to each participant.

Blinding：

Participants will be randomly assigned to one of the 16 experimental conditions using computer generated random numbers. No interaction between participants will occur, thus the experimental conditions will be blinded to each participant.

是否共享原始数据：

IPD sharing

否No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

NA

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

NA

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

NA

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

NA

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2023-05-09 09:11:39